Lymphocyte-Depleting Nonmyeloablative Preparative Chemotherapy Followed By Autologous Lymphocyte Infusion, Peptide Vaccine Plus Montanide ISA-51, and Interleukin-2 in Treating Patients With Metastatic Melanoma

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Treating a person's lymphocytes in the laboratory and reinfusing them may replace immune cells destroyed by chemotherapy. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells.

PURPOSE: This phase II trial is studying how well lymphocyte-depleting nonmyeloablative (not damaging to bone marrow) chemotherapy followed by autologous lymphocyte infusion, peptide vaccine plus Montanide ISA-51, and interleukin-2 works in treating patients with metastatic melanoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Freund's Adjuvant; Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of metastatic melanoma that is refractory to standard therapy (including high-dose interleukin-2)

• Measurable disease

• HLA-A*0201 positive

• Epstein-Barr virus positive

• ESO-1-expressing disease by reverse transcription polymerase chain reaction amplified tissue OR presence of ESO-1 serum antibody

PATIENT CHARACTERISTICS:

Age

• 16 and over

Performance status

• ECOG 0-1

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3

• Platelet count > 100,000/mm^3

• Hemoglobin > 8.0 g/dL

Hepatic

• Hepatitis B surface antigen negative

• Hepatitis C antibody negative

• AST and ALT < 3 times upper limit of normal

• Bilirubin ≤ 2.0 mg/dL (< 3.0 mg/dL for patients with Gilbert's syndrome)

• No coagulation disorders

Renal

• Creatinine ≤ 2.0 mg/dL

Cardiovascular

• No prior myocardial infarction

• No major cardiovascular illness by stress thallium or comparable test

• No cardiac arrhythmias

• LVEF ≥ 45%

• Normal cardiac stress test required for the following conditions:

• Prior EKG abnormalities

• Symptoms of cardiac ischemia

• Arrhythmias

• Age 50 and over

Pulmonary

• FEV_1 > 60% of predicted (for patients with a prolonged history of cigarette smoking or symptoms of respiratory dysfunction)

• No obstructive or restrictive pulmonary disease

• No other major respiratory illness

Immunologic

• HIV negative

• No active systemic infection

• No opportunistic infection

• No major immune system illness

• No form of primary or secondary immunodeficiency

• No known hypersensitivity to study agents

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for at least 4 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• Prior ESO-1-based vaccination allowed

Chemotherapy

• At least 6 weeks since prior nitrosoureas and recovered

Endocrine therapy

• No concurrent systemic steroid therapy

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• Not specified

Other

• At least 4 weeks since prior systemic therapy